A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Study of Long-Term Treatment for Moderately to Severely Active Ulcerative Colitis

Age
16 years - 80 years
Gender
All
Phase
Phase 3
Participants needed
751
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Study Overview

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).

Study details include:

The study duration may be up to 286 weeks including:

  • 40-week Pivotal Maintenance Sub-Study
  • 240-week Open-Label Extension (OLE) Sub-Study
  • 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.

The treatment duration may be up to 280 weeks including:

  • 40 weeks in Pivotal Maintenance Sub-Study
  • 240 weeks in OLE Sub-Study

The total number of on-site visit will be up to 32:

  • 21 visits in the Pivotal Maintenance Sub-Study.
  • 11 visits in the OLE Sub-Study.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: 16 years - 80 years
  • Gender: All

Inclusion Criteria:

  • Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development)
  • Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1
  • OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Exclusion Criteria:

  • Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
  • Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

The purpose of this research study is to learn about the effects and safety of an investigational study drug in people with moderately to severely active ulcerative colitis.

Participants will receive either the investigational study drug or a placebo. A placebo looks like the investigational study drug but does not contain active medication. Some participants may continue in a longer-term part of the study where everyone receives the investigational study drug.

Who can participate:
Adults with ulcerative colitis may be able to participate if they:

  • Are 18 to 80 years old (in some locations, certain 16 to 17 year olds may be able to join)
  • Previously took part in a related ulcerative colitis study and had improvement and a completed endoscopy (a camera test to look inside the bowel)
  • Complete the first part of this study (or took part in another related study) to be able to join the longer-term part

Study timeline and visits:
Participation may last up to 286 weeks. People who do not continue into the longer-term part may be in the study for up to 46 weeks. There will be up to 32 in-person study visits.

Updated on 14 Oct 2026. Study ID: NCT07185009

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